(27 days)
The Convey Guiding Catheter is designed to provide a pathway through which therapeutic and diagnostic devices are introduced. The Convey Guiding Catheter is intended to be used in the coronary or peripheral vascular system.
The guiding catheter is a flexible plastic tube featuring a luer hub, a strain relief, a body, an intermediate tip, and a soft tip. The body and the intermediate tip exist of an inner liner (basecoat) and an outer jacket (topcoat) reinforced with a tightly wound stainless steel braid wire in between the layers. The central lumen of the catheter is used for the percutaneous, transluminal passage and placement of guidewires, diagnostic and / or therapeutic (interventional) devices within the vascular system. The distal section of the catheter has a variety of preformed shapes (e.g., Judkins Left (abbreviated as JL), Judkins Right (JR), Amplatz (AL), Multipurpose, hockey stick) to facilitate placement of the catheter tip in the desired target vessel. Some catheter models feature two (2) small "inline" side holes in the intermediate tip section to maintain perfusion of the target vessel. This device is a single-use device (i.e., single patient, single procedure, single purpose use). After finalizing the procedure, the catheter is withdrawn, removed and discarded.
Here's an analysis of the acceptance criteria and study information based on the provided text, structured according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text focuses on the design verification and substantial equivalence of the Convey™ 7F and 8F Guiding Catheters to predicate devices (Convey™ 5F and 6F). It lists various in-vitro performance tests that were conducted to ensure the device conforms to requirements. However, it does not explicitly state quantitative acceptance criteria or numerical performance results for each test. Instead, it implies that the device successfully met the requirements through these tests to establish substantial equivalence.
Therefore, the table below will list the tests performed, as these represent the areas where acceptance would have been determined, but will note the absence of explicit quantitative criteria or reported performance values in the provided document.
| Acceptance Criterion (Test Performed) | Reported Device Performance (as implied by document) |
|---|---|
| Visual Inspection | Conforms to requirements |
| Shape Conformance & Shape Retention | Conforms to requirements |
| Outer Diameter | Conforms to requirements |
| Inner Diameter | Conforms to requirements |
| Usable Catheter Length | Conforms to requirements |
| Side Hole diameter & positioning | Conforms to requirements |
| C-Kink (Bending Kink Diameter) | Conforms to requirements |
| Euler Kink (Axial Kink Displacement) | Conforms to requirements |
| Radial Stiffness (Collapse) | Conforms to requirements |
| Three Point Bending Test (Bending Stiffness Body) | Conforms to requirements |
| Pull Force Test (after simulated use) | Conforms to requirements |
| Coating location & length | Conforms to requirements |
| Coating Integrity - Outer Friction & Wear functional test | Conforms to requirements |
| Coating Integrity (after simulated use) | Conforms to requirements |
| Torque Strength (after simulated use) | Conforms to requirements |
| Body Strength / Burst Pressure test | Conforms to requirements |
| Particulate testing | Conforms to requirements |
| Radiopacity / Visibility testing | Conforms to requirements |
| Bacterial Endotoxin-Mediated Pyrogenicity Testing | Conforms to requirements |
| Bioburden testing | Conforms to requirements |
| Ethylene Oxide Residual Testing | Conforms to requirements |
| ISO 10993-4: Haemocompatibility (Hemolysis, In vitro Haemocompatibility, Coagulation) | Conforms to requirements |
| ISO 10993-5: Cytotoxicity - MEM-elution | Conforms to requirements |
| ISO 10993-7: Ethylene Oxide Sterilization Residuals | Conforms to requirements |
| ISO 10993-10: Sensitization | Conforms to requirements |
| ISO 10993-10: Irritation / Intracutaneous Reactivity | Conforms to requirements |
| ISO 10993-11: Acute Systemic Toxicity | Conforms to requirements |
| ISO 10993-11: Material Mediated Pyrogenicity | Conforms to requirements |
| USP : Packaging Plastic Containers Leachables | Conforms to requirements |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document states that "The following in-vitro performance tests... were completed of the 7F & 8F Convey Guiding Catheter." However, it does not specify the number of units tested (sample size) for each of these non-clinical, in-vitro (bench) tests.
- Data Provenance: The tests are described as "non-clinical design verification (bench) tests." The document does not specify the country of origin of the data or whether it was retrospective or prospective, but given it's bench testing for a new device, it would be prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable / not provided in the document. The studies described are non-clinical, bench-top performance tests, sterility tests, and biocompatibility tests. These do not typically involve human experts establishing "ground truth" in the way clinical studies or diagnostic AI studies do. The ground truth for these tests would be the established scientific and engineering standards and methods for assessing material properties and device performance.
4. Adjudication Method for the Test Set
This information is not applicable / not provided. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies where multiple human readers interpret data (e.g., medical images) to establish a consensus ground truth. The studies cited are non-clinical, bench tests.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Since the modifications do not have an impact on the indications for use and on the safety and performance of the device, a Clinical Evaluation Study was not regarded for these devices." This indicates no human clinical studies were performed for the 7F and 8F guiding catheters. Furthermore, this device is a physical medical device (catheter), not an AI algorithm, so the concept of human readers improving with AI assistance does not apply.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. The device is a physical guiding catheter, not an AI algorithm.
7. The Type of Ground Truth Used
For the non-clinical tests (performance, sterility, biocompatibility), the "ground truth" is based on:
- Established scientific and engineering principles: for physical performance tests (e.g., kink resistance, stiffness, strength, dimensions).
- International standards (e.g., ISO 10993) and USP pharmacopeia tests: for biocompatibility, sterility, and endotoxin testing.
- Manufacturing specifications: for attributes like visual inspection, dimensions, coating properties, etc.
8. The Sample Size for the Training Set
This is not applicable. The device is a physical medical device. It does not use a "training set" in the context of machine learning or AI. The design and validation are based on engineering principles and regulatory standards rather than data training.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set for a physical medical device in this context.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).